Kornimate/medical-research-clean huggingface dataset:
a clinical trial of decitabine in patients with myelodysplastic syndrome

Conditions: Myelodysplastic Syndrome

Summary: the purpose of this study was to determine which of the doses of decitabine maximizes genomic demethylation in patients with myelodysplastic syndrome (mds).

phase i: the purpose of this study was to determine which of the subcutaneous doses of decitabine administered twice daily for 5 days maximizes genomic demethylation in patients with mds phase ii: to evaluate hematological responses at the dose selected in the phase i portion of the study. note: this study was planned as phase 1/2 study but only the phase 1 part was conducted due to a change in product development strategy

Eligibility criteria:
inclusion criteria: 1. eastern cooperative oncology group (ecog) performance status score of 0-2. 2. confirmed diagnosis of mds or non-proliferative chronic myelomonocytic leukemia (cmml). exclusion criteria: 1. prior therapy with decitabine or azacytidine (vidaza). 2. experimental or standard drugs for the treatment of mds within 28 days of the first day of study drug treatment. 3. clinically significant anemia. 4. prior history of malignancy other than mds. 5. any active infection. 6. radiotherapy within 14 days prior to study enrollment.

Keywords: myelodysplastic syndrome mgi pharma decitabine dacogen
analysis of screen-detected lung cancers' genomic traits

Conditions: Lung Cancer

Summary: prospective, observational cohort study of patients undergoing surgical resection for low dose ct (ldct) screen-detected lung cancer (detected through the summit study- clinicaltrials.gov identifier: nct03934866/ lung screening programmes), in which translational research is a fundamental aspect.

the ascent study seeks to examine the genomic signatures of screen-detected cancers, in order to categorise the biological behaviour of such lesions and correlate this against non-invasive biological and radiological parameters. from these data, the plan is to explore strategies to characterise ldct-detected cancers through non-invasive means, which the researchers believe may prove key in mitigating potential screening-associated harms.

Eligibility criteria:
inclusion criteria: 1. diagnosed with confirmed lung cancer or probable lung cancer via ldct screening. 2. planned for, or completed primary surgical resection either for histologically confirmed lung cancer, or strongly suspected lung cancer. 3. able to provide written informed consent (or verbal informed consent for participants consenting to retrospective diagnostic samples and data collection only). exclusion criteria: 1. treatment with neoadjuvant therapy for current lung malignancy as per local mdt treatment decision. 2. known active human immunodeficiency virus (hiv), hepatitis b virus, hepatitis c virus or syphilis.

Keywords: genomic signatures screen-detected cancer non-invasive biological and radiological parameters
an open-label study to assess safety

Conditions: Plaque Psoriasis

Summary: an open-label study to assess safety

an open-label study to assess the efficacy and potential for adrenal suppression following maximal use treatment with ta-102 topical formulations in subjects with plaque psoriasis.

Eligibility criteria:
inclusion criteria: 1. healthy male or non-pregnant female aged ≥ 18 years with a clinical diagnosis of plaque psoriasis. 2. definite clinical diagnosis of stable plaque psoriasis for at least 6 months. 3. subjects must be in good health and free from any clinically significant disease, including but not limited to, conditions that may interfere with the evaluation of plaque psoriasis. exclusion criteria: 1. female subjects who are pregnant, nursing or planning to become pregnant during study participation. 2. history of allergy or sensitivity to retinoid, corticosteroids and/or history of any drug hypersensitivity or intolerance which, in the opinion of the investigator, would compromise the safety of the subject or the results of the study.
analgesic effects of us bilateral rectus sheath block for laparoscopic gy surgery

Conditions: Gynecologic Disease

Summary: rectus sheath block (rsb) is a kind of anterior abdominal wall block. it has postoperative analgesic effect for abdominal surgery with midline incision. laparoscopic gynecologic surgery is accompanied by significant postoperative pain and usually iv-pca is used to manage the pain.the purpose of this study is to investigate the analgesic effect of ultrasound-guided rsb to multi-port laparoscopic gynecologic surgery which has incision site at umbilical area. patients will randomly assigned to two groups, rsb group and control group. each patients will assessed for time to first rescue analgesia, verbal numerical rating pain scores, number of rescue analgesic demands, and postoperatively opioids use by iv-pca by a blinded investigator at 0, 1, 6, 12, 24 and 48 hours postoperatively.

patients of rsb group will be performed ultrasound-guided bilateral rsb after induction of general anesthesia. the procedure will be performed bilaterally and 15 ml on each side, total 30 ml of 0.25% ropivacaine will be injected. after the procedure, a surgery scheduled will be proceeded. patient of control group will be proceeded the surgery after induction of anesthesia. all patients will use total 100 ml of iv-pca containing 800 µg of fentanyl with 150 mg of ketorolac for 48 hours postoperatively. if a patient complains pain more intense than vnrs 4 or demands an analgesic drug, a rescue analgesic would be allowed.

Eligibility criteria:
inclusion criteria: * multi-port laparoscopic gynecologic surgery * american society of anesthesiologists (asa) physical status classification i-ii * age: 21-60 exclusion criteria: * gynecologic cancer operation * history of previous abdominal surgery * allergy to local anesthetics(ropivacaine) * opioid tolerance * coagulopathy * infection at the needle insertion site * difficulty to cooperating
vitamin b6 in reducing hot flashes in participants with prostate cancer undergoing antiandrogen therapy

Conditions: Hot Flashes; Prostate Carcinoma

Summary: this pilot phase ii trial studies how well vitamin b6 works in reducing hot flashes in participants with prostate cancer undergoing antiandrogen therapy. a nutritional supplement such as vitamin b6 may help improve hot flashes caused by antiandrogen therapy in participants with prostate cancer.

primary objectives: i. to evaluate the effect of vitamin b6 in improves the frequency or severity of hot flashes in prostate cancer patients receiving antiandrogen therapy (androgen deprivation therapy \[adt\]). outline: participants receive vitamin b6 orally (po) daily for 12 weeks.

Eligibility criteria:
inclusion criteria: * subjects are currently receiving adt for prostate cancer and will continue on adt for at least 13 weeks after enrollment. patient may have been started on adt at any past time point because patients experience hot flashes throughout adt treatment * subjects are experiencing bothersome hot flashes per the study questionnaires * subjects are capable of giving informed consent. * willing to comply with all study procedures and be available for the duration of the study * able to obtain and take an acceptable form of vitamin b6 exclusion criteria: * subjects without a diagnosis of prostate cancer * subjects already receiving other treatment for hot flashes * subjects taking selective serotonin reuptake inhibitors (ssris) * subjects are currently taking vitamin supplementation which includes vitamin b6 at doses \> 10 mg
multiple dose study of trx0037

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of trx0037 after multiple doses in elderly volunteers.


Eligibility criteria:
inclusion criteria: * male and female 55 and over * no clinically important abnormal physical finding * no clinically significant lab results * normal ecg * normal bp and hr * bmi between 19 and 32 * weight 50 to 100 kg * able to communicate * provide written informed consent * non smokers * males to use contraception * females to be surgically sterile or post menopausal exclusion criteria: * administration of any imp other than study drug within 12 weeks before entry * use of any prescribed meds, st john's wort, over the counter meds as described in the protocol * surgical or medical condition that might interfere with imp * history of drug or alcohol abuse * clinically significant allergy requiring treatment * loss of greater than 400ml of blood within 12 weeks. * serious adverse reaction or hypersensitivity to any drug * presence of hep b, hep c or hiv-1 or hiv-2 at screening * presence of g6pd at screening * history of methaemoglobinaemia * partner who is pregnant of lactating * positive pregnancy test
ozurdex implant for macular edema after treatment failure with anti-vegf

Conditions: Retinal Vein Occlusion (RVO); Macular Edema

Summary: to determine if ozurdex implant can offer an effective treatment for macular edema associated with retinal vein occlusion when treatment with intravitreal avastin, lucentis, or eylea have not demonstrated a significant response.

to determine whether ozurdex implant can offer an efficacious alternative for treatment of macular edema in the setting of retinal vein occlusion when treatment with intravitreal bevacizumab (avastin),ranibizumab (lucentis), and/or aflibercept (eylea) have not demonstrated significant response.

Eligibility criteria:
inclusion criteria: all patients with retinal vein occlusion (rvo) with available initial imaging and documented treatment failure with bevacizumab, ranibizumab, or aflibercept. treatment failure is defined as lack of anatomic improvement (persistent intraretinal cystic changes/macular edema with central subfield thickness greater than 250 microns on time-domain oct or greater than 275 microns on spectral domain oct) with lack of visual improvement (less than 2 lines of visual gain by snellen acuity), despite 3 to 6 intravitreal anti-vegf treatments over the preceding 6 months. exclusion criteria: * co-existing or pre-existing macular degeneration, diabetic macular edema, or other confounding disease processes * interval surgical intervention, such as cataract surgery, that may confound visual outcomes. * pregnancy * coexisting conditions that would represent relative or absolute contraindications usage of ozurdex implant, including: * ocular or periocular infections (including viral disease of the cornea and conjunctiva such as active epithelial herpes simplex keratitis, vaccinia, varicella, mycobacterial infection, and fungal diseases) * advanced glaucoma * aphakic eyes with rupture or missing posterior lens capsule * eyes with anterior chamber intraocular lens and missing posterior lens capsule * patients with known hypersensitivity to components of this product
antimicrobial dressing versus standard dressing in obese women undergoing cesarean delivery

Conditions: Cesarean Section Complications; Wound Breakdown; Wound Infection; Satisfaction; Surgical Wound Infection

Summary: this will be an open label pilot randomized controlled clinical trial. women undergoing cesarean delivery will be randomized to have standard wound dressing care or chlorohexidine gluconate (chg) impregnated wound dressing (reliatect™ post-op dressing).

subjects requiring cesarean delivery and without exclusion criteria will be informed by the obstetrical team about the study and asked for permission to contact the study personnel. written informed consent will be obtained by person-to-person contact. the research staff will be responsible for the informed consent. subjects who agree to participate in the study will be randomized to one of the two groups below in a 1/1 allocation: * standard wound care: wound dressing and care as per our current practice. compression dressing consisting of gauze, tefla and adhesive tape will be placed intraoperatively. dressing will be removed after 24 hours from surgery completion and subjects will have an absorption pad with overlying garments for the remaining postoperative days until standard postoperative visit for wound check. * chg wound care: reliatect™ post-op dressing will be applied as per the manufacturer's instructions (appendix a) intraoperatively. the dressing will be in place until the postoperative clinic visit on postoperative day 7. the remainder of the subjects' care will be similar for both arms and will follow current standard clinical practice at the university of texas medical branch (utmb).

Eligibility criteria:
inclusion criteria: * 18-50 years of age. * women ≥ 24 weeks' viable gestation. * to undergo cesarean delivery. * admission bmi ≥ 35. exclusion criteria: * patient unwilling or unable to provide consent. * no prenatal care or a non-resident patient who is unlikely to be followed-up after delivery. * immunosuppressed subjects: i.e., taking systemic immunosuppressant or steroids (e.g. transplant subjects; not including steroids for lung maturity), hiv with cd4 \<200, or other. * decision not to have skin closure (e.g. secondary wound closure, mesh closure). * current skin infection. * coagulopathy. * high likelihood of additional surgical procedure beyond cesarean (e.g. scheduled hysterectomy, bowel or adnexal surgery). * known allergy to chg. * incarcerated individuals. * chorioamnionitis. * subjects participating on other treatment trials or studies that would interfere with the current study's primary outcome.

Keywords: cesarean wound care wound complication surgical site infection
plr and nlr as predictor factors for semen abnormality

Conditions: Fertility Issues

Summary: the aim of this study was to evaluate the relationship of seminal parameters with the neutrophil-to-lymphocyte ratio (nlr) and the platelet-to-lymphocyte ratio (plr), which are inflammatory markers, in men with an abnormal semen analysis and men with normozoospermia.


Eligibility criteria:
inclusion criteria: * adult above 18 years primary not do varicocelectomy exclusion criteria: * young secondry infertility recurrent varicocele
reliability of ultrasound assisted epidural analgesia in obese and normal weight parturients

Conditions: Pregnancy

Summary: this study wants to investigate if ultrasound assisted epidural catheter insertion for labor analgesia is easier and safer to the standard epidural technique.

this study has four specific aims: 1. to evaluate congruity between palpatory technique and ultrasound lumbar evaluation to identify the correct spinal space; 2. to compare between ultrasound evaluation and needle measure of skin-epidural space depth; 3. to compare between longitudinal and transverse ultrasound epidural space depth in obese and normal parturients; 4. to check the reduction of complications and failure rates of epidural analgesia with ultrasound assistance.

Eligibility criteria:
inclusion criteria: * all women who request epidural analgesia for labor exclusion criteria: * all women who present contraindication for epidural analgesia

Keywords: epidural analgesia ultrasound labor analgesia labor
retrieval practice and schizophrenia

Conditions: Schizophrenia; Episodic Memory Deficits

Summary: when people are tested on a previously learned material, they will later remember it better even when compared to a condition where they can re-study it. this phenomenon is called retrieval practice and is supported by an extensive research literature mostly carried out in normal students. this paradigm begins to be used in cognitive remediation programs in patients suffering from memory difficulties. the objective of this study is to investigate whether retrieval practice is spared in patients with schizophrenia. if effective, this method could be used in cognitive remediation programs. since episodic memory difficulties are supposed to be secondary to deficits in the initiation/elaboration of efficient encoding and retrieval strategies our hypothesis is that retrieval practice is spared in schizophrenia.


Eligibility criteria:
inclusion criteria: * french is the native language, or acquired before 5 years old * people must be able to understand and follow the trial instructions specific inclusion criteria (for patients) : * diagnostic of schizophrenia, according to the dsm -5, clinically stable * the treatment must remain unchanged during the trial exclusion criteria: * severe or acute cerebral disease * other actual psychiatric disorder * use of drugs with high anticholinergic effect * irregular use of benzodiazepines medication, or high dose of benzodiazepin (more than 2 mg of lorazepam per day or equivalent) * inappropriate use of drugs specific exclusion criteria (for healthy subjects) : - diagnostic of schizophrenia of a relative up to the third degree

Keywords: schizophrenia episodic memory deficits
a study to assess the efficacy and safety of efgartigimod iv in adult participants with primary immune thrombocytopenia

Conditions: Primary Immune Thrombocytopenia (ITP)

Summary: the main purpose of this study is to look at the effect (efficacy) and safety of efgartigimod iv in participants with primary immune thrombocytopenia (itp). after an up to 2 weeks screening period, eligible participants will be randomized in a 2:1 ratio to receive either efgartigimod iv or placebo iv, respectively during the double-blinded treatment period (dbtp). at the end of the treatment period (up to 24 weeks), all participants will receive efgartigimod iv during the first 52-week open-label treatment period (oltp1). at the end of the first oltp1, participants may begin a second 52-week oltp2. after the oltp2, the participants will enter a follow-up period (approximately 8 weeks) while off study drug. the participants will be in the study for up to 138 weeks.


Eligibility criteria:
inclusion criteria: * is at least 18 years of age and the local legal age of consent for clinical studies when signing the informed consent form (icf). * has documented baseline mean platelet count of \<30 x 10\^9/l before randomization * has a documented duration of primary immune thrombocytopenia (itp) of more than 12 months on the date of informed consent form (icf) signature. * has documented prior itp treatment with at least 1 of the following treatments: corticosteroids, intravenous immunoglobulin (ivig), anti-d immunoglobulin, thrombopoietin receptor agonist (tpo-ras), or rituximab. * has documented insufficient response to a prior itp treatment (the specific criteria can be found in the protocol). * has documented prior response defined as 1 platelet count of ≥50 × 109/l to at least 1 of the following itp treatments in the 3 years before the date of icf signature: prednisone, dexamethasone, other or nonspecified corticosteroids, ivig, or anti-d immunoglobulin exclusion criteria: * other than the indication under study, known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of itp, confound the results of the study or put the participant at undue risk. * secondary itp * nonimmune thrombocytopenia * autoimmune hemolytic anemia * itp-associated critical or severe bleeding the complete list of criteria can be found in the protocol.
comparison of combination disease modifying antirheumatic drugs with methotrexate therapy in early rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this study will be conducted to find out how well a patient of rheumatoid arthritis (ra) will respond to disease-modifying antirheumatic drugs (dmards). ra is a chronic inflammatory arthritis, which leads to joint damage \& disability if not treated properly. a dmard is used to treat ra that slows down or prevents joint damage, as opposed to just relieve pain or inflammation by painkillers. the study will be conducted at the department of clinical immunology, jipmer (jawaharlal institute of postgraduate medical education \& research). patients will receive either a single dmard (methotrexate) or combination dmards therapy (methotrexate + leflunomide + hydroxychloroquine). during treatment course, routine blood investigations will be carried out to monitor treatment response and side effects.

patients aged ≥18 years, fulfilling the 2010 acr eular criteria for ra (symptom duration less than one year) \& having moderate to severe disease activity (das28≥3.2) will be invited to participate. after providing written informed consent, eligible patients will be stratified into two groups. block randomization will be done to generate random allocation sequence. treatment group i will be treated with methotrexate (mtx) monotherapy and treatment group ii will be treated with methotrexate + leflunomide (lef) + hydroxychloroquine (hcq) combination therapy. concurrent treatment with non-steroidal anti-inflammatory drugs in adequate dose and oral low dose glucocorticoids (gc) (max: 15 mg/d) will be allowed during the study. dmard dosages used are: mtx 25 mg/week orally (dosage after 6 weeks), lef 20 mg/day (dosage after 2 weeks) and hcq 400 mg/day. gcs will be given in an oral tapering scheme. all patients will be prescribed folic acid (10 mg/week) during mtx prescription.

Eligibility criteria:
inclusion criteria: 1. age \> 18 years satisfying 2010 acr (american college of rheumatology) - eular criteria for ra 2. arthritis in one or more joint (s) 3. symptom duration \<1 year 4. dmard naive 5. patients with moderate to severe disease activity (das28 ≥3.2) exclusion criteria: 1. disease in remission/inactive disease (das28 criteria) 2. end stage disease (deformed fixed joints) 3. patients with vasculitis or other severe extra-articular features 4. contraindications to dmard therapy (chronic alcoholism, chronic liver disease, evidence of acute/chronic infection, chronic kidney disease, patients with leucopenia (\ 2× upper normal value and creatinine level \>150 μmol/l ) 5. pregnant, lactating females or inadequate contraception 6. patients unable to come for regular follow up